"Ventricular Tachycardia Ablation Registry".
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|ClinicalTrials.gov Identifier: NCT03649022|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Catheter ablation of Ventricular Tachycardias is a well-established approach in clinical practice in patients with Implantable Cardioverter Defibrillator (ICD) implanted. Previous studies have shown a significant reduction in appropriate shocks (~ 20%) and a significant reduction in hospitalizations for cardiovascular reasons (~ 12%) in patients with ischemic heart disease treated with ablation. Recent works have also shown the effectiveness of the ablation procedure using as procedural target the reduction of late potentials. However, actually it is necessary to have an homogenize and accepted mapping scheme in Sinus Rhythm to ablate Ventricular Tachycardias related to scar substrate in patients with:
- Previous MI
- Previous myocarditis
- Arrhythmogenic Right Ventricular Dysplasia (ARVD)
- Idiopathic Dilated Cardiomyopathy (IDCM)
Scope of the registry is to collect data during cardiac mapping in Sinus Rhythm in patients indicated for Ventricular Tachycardia ablation, that will be performed per clinical practice, by using the St. Jude Medical EnSiteTM PrecisionTM mapping system.
The objective of the present registry is: to assess the acute and long-term efficacy of the strategy of substrate abolition (abolishment of complex and late potentials) guided by electroanatomic mapping with Precision software.
|Condition or disease||Intervention/treatment|
|Ventricular Tachycardia||Device: Catheter ablation|
This is an Italian multicenter, observational, prospective and retrospective registry.
Data will be collected during enrollment/baseline, procedure, pre-discharge and during the follow-up visits according to the standard practice of participating centers, with mandatory visits at 6 and 12 months. Data can also be collected retrospectively, prior informed consent of the patient.
The planned enrollment duration is approximately 24 months.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||"Ventricular Tachycardia Ablation Registry". Italian Registry of Substrate Mapping and VT Ablation With the Precision Mapping System and Flexability Catheter.|
|Actual Study Start Date :||July 25, 2017|
|Estimated Primary Completion Date :||July 25, 2020|
|Estimated Study Completion Date :||July 25, 2020|
- Device: Catheter ablation
Ventricular Tachycardia ablation, that will be performed per clinical practice, by using EnSite Precision mapping system with the Flexability catheter (St.Jude, now Abbott)
- Late potential abolition and ventricular tachycardia noninducibility [ Time Frame: Intraprocedural ]
Combined procedural endpoint of late potential (LP) abolition and VT noninducibility (endpoint expected in 50% of cases).
LP abolition assessed as % of persistent LP area at remap after ablation, compared to the basal activation map.
- Ventricular tachycardia recurrence [ Time Frame: 12 months ]Freedom from Ventricular Tachycardia episodes requiring ICD Intervention (shock or Anti-Tachycardia Pacing)
- Complications [ Time Frame: During hospitalization: starting during the procedure until discharge ]Periprocedural complications
- Complications [ Time Frame: 12 months ]Long term catheter ablation complications
- Procedural parameters [ Time Frame: Intraprocedural ]Procedure duration measured in minutes
- Procedural parameters [ Time Frame: Intraprocedural ]Fluoroscopy exposure measured in Gycm2
- Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]Geometry precision, descriptive
- Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]Mapping accuracy, descriptive
- Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]System overall stability, descriptive
- Assessment of cardiac mapping system EnSite Precision™ software (St.Jude, now Abbott) [ Time Frame: Intraprocedural ]Non-recoverable shifts/drifts, descriptive
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649022
|Contact: Andrea Radinovic, MDemail@example.com|
|IRCCS San Raffaele||Recruiting|
|Milan, Italy, 20132|
|Contact: Paolo Della Bella, MD +390226437379 firstname.lastname@example.org|
|Contact: Andrea Radinovic, MD +390226437379 email@example.com|
|Principal Investigator:||Paolo Della Bella, MD||IRCCS S Raffaele|